SITAGLIPTIN EXELTIS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sitagliptina Exeltis 100mg Film-Coated Tablets EFG

sitagliptina

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sitagliptina Exeltis and what is it used for
2. What you need to know before you take Sitagliptina Exeltis
3. How to take Sitagliptina Exeltis
4. Possible side effects
5. Storage of Sitagliptina Exeltis
6. Contents of the pack and further information

1. What is Sitagliptina Exeltis and what is it used for

Sitagliptina Exeltis contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medicine helps to increase the amount of insulin produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medicine to help you reduce your blood sugar level, which is too high due to your type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that reduce blood sugar levels, which you may already be taking for your diabetes, together with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease in which your body does not produce enough insulin, and the insulin it does produce does not work as well as it should. Your body may also produce too much sugar.

When this happens, sugar (glucose) builds up in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Sitagliptina Exeltis

Do not take Sitagliptina Exeltis

• If you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with sitagliptin (see section 4).

If you notice blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptina Exeltis.

Tell your doctor if you have or have had:

• pancreatic disease (such as pancreatitis);
• gallstones, alcohol dependence, or very high blood levels of triglycerides (a type of fat).

These medical conditions may increase your risk of developing pancreatitis (see section 4).

• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any current or past kidney problems;
• an allergic reaction to sitagliptin (see section 4).

It is unlikely that this medicine will cause low blood sugar because it does not work when your blood sugar level is low. However, when this medicine is used in combination with a medicine that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medicine.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents between 10 and 17 years of age. It is not known if this medicine is safe and effective when used in children and adolescents under 10 years of age.

Other medicines and Sitagliptina Exeltis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood levels if you are taking Sitagliptina Exeltis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be taken during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with sulfonylureas or insulin may cause low blood sugar, which may affect your ability to drive or use machines or work without a safe support.

Sitagliptina Exeltis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Sitagliptina Exeltis

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is

• one 100 mg film-coated tablet
• once a day
• by mouth.

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).

You can take this medicine with or without food and drinks.

Your doctor may prescribe this medicine alone or with other medicines that also reduce blood sugar levels.

Diet and exercise can help your body use sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking sitagliptina.

If you take more Sitagliptina Exeltis than you should

If you take more of this medicine than you should, contact your doctor immediately.

If you forget to take Sitagliptina Exeltis

If you forget to take a dose, take it as soon as you remember. If you do not remember until the time for the next dose, then skip the missed dose and continue with your regular schedule.

Do not take a double dose of this medicine.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you stop taking Sitagliptina Exeltis

Keep taking this medicine while your doctor tells you to, in order to keep your blood sugar level under control. Do not stop taking this medicine without first talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Sitagliptina Exeltis and contact a doctor immediatelyif you notice any of the following serious side effects:

• Severe and persistent abdominal pain (in the stomach area) that may radiate to the back, with or without nausea and vomiting, as these may be signs of pancreatitis.

If you have a severe allergic reaction (frequency not known) that includes skin rash, hives, blisters on the skin, or peeling of the skin and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and a different treatment for your diabetes.

Some patients experienced the following side effects after adding sitagliptin to their treatment with metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, and vomiting. Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, and somnolence.

Some patients experienced different types of stomach discomfort when they started taking sitagliptin with metformin (frequency classified as common).

Some patients experienced the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar

Common: constipation

Some patients experienced the following side effects while taking sitagliptin and pioglitazone: Common: flatulence, swelling of hands or feet

Some patients experienced the following side effects while taking sitagliptin with pioglitazone and metformin:

Common: swelling of hands or feet

Some patients experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):

Common: flu

Uncommon: dry mouth

Some patients experienced the following side effects while taking sitagliptin alone during clinical trials or after marketing authorization, alone or with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg

Uncommon: dizziness, constipation, itching

Rare: reduced platelet count

Frequency not known: kidney problems (which may require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptina Exeltis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or bottle and on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Sitagliptina Exeltis

The active substance is sitagliptin.

Sitagliptina Exeltis 100 mg film-coated tablets: Each film-coated tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.

The other ingredients are:

• Core of the tablet:calcium hydrogen phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate.
• Coating (100 mg):polyvinyl alcohol, titanium dioxide, macrogol, talc, yellow iron oxide, and red iron oxide.

Appearance of the product and pack contents

Sitagliptina Exeltis 100 mg film-coated tablets: Film-coated tablets, round, biconvex, approximately 9.8 mm in diameter, beige in color, engraved with "L" on one side and smooth on the other.

The 100 mg film-coated tablets of Sitagliptina Exeltis are packaged in

• opaque PVC/PVDC-aluminum blisters containing

10, 14, 28, 30, 98, 100, 105, and 120 film-coated tablets.

• White high-density polyethylene (HDPE) bottle with a desiccant gel compartment in a polypropylene screw cap, containing 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Exeltis Healthcare S.L.

Avenida de Miralcampo 7,

19200, Azuqueca de Henares (Guadalajara)

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Av. Miralcampo, 7

19200, Azuqueca de Henares (Guadalajara)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Sitagliptin Liconsa 100 mg Filmtabletten

Spain: Sitagliptina Exeltis 100 mg Comprimidos recubiertos con película EFG

Date of last revision of this leaflet: July 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)